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鎴愰兘娆ф灄鐢熺墿绉戞妧鑲′唤鏈夐檺鍏徃閲囪喘浣宠埅鍏ㄨ嚜鍔ㄧ啍鐐逛华
鍙戝竷鏃堕棿锛
2021-05-18 00:00
璐拱鍘傚锛欬/span>鎴愰兘娆ф灄鐢熺墿绉戞妧鑲′唤鏈夐檺鍏徃 鏃堕棿锛欬/span>2021骞滁/span>4鏈圏/span>
浜у搧鍚嶇О锛欬/span>鍏ㄨ嚜鍔ㄧ啍鐐逛华 瑙勬牸鍨嬪彿锛欴igipol-M70
鎴愰兘娆ф灄鐢熺墿绉戞妧鑲′唤鏈夐檺鍏徃鍒涘缓浜嶞/span>2009骞达紝鏄竴瀹朵笓娉ㄤ簬浜虹敤鐤嫍鐮斿彂銆佺敓浜у拰閿€鍞仛鐒︿簬鍒涙柊浜у搧鐨勫浗瀹堕珮鎶€鏈紒涓氥€傝吹鍏徃绉夋壙“寮哄寲杩囩▼绠＄悊锛岃嚧鍔涙寔缁敼杩涳紝杩芥眰鏈€楂樺搧璐?rdquo;鐨勭粡钀ョ悊蹇碉紝浠ユ垚涓?ldquo;鍥介檯鐭ュ悕銆佸浗鍐呴鍏?rdquo;鐨勭柅鑻椾緵搴斿晢涓哄彂灞曞畻鏃ㄣ€傚湪鑽搧鐢熶骇杞﹂棿寤鸿鍜岀鐞嗘柟闈紝鍏徃鍦ㄧ鍚堟垜鍥?010鐗圙MP鍩虹涓婏紝鍙傜収娆х編鍙戣揪鍥藉鏍囧噯寤鸿鍜岀鐞嗭紝涓哄叕鍙镐骇鍝佽繘鍏ュ浗闄呭競鍦烘墦涓嬪潥瀹炲熀纭€銆傚湪浜у搧寮€鍙戞柟闈紝鍏徃瀹炶“鍒涙柊鐤嫍寮€鍙?浼犵粺鐤嫍鍗囩骇鎹唬”鍙岃疆椹卞姩鍜?ldquo;鑷富鐮斿彂+鑱斿悎鐮斿彂”鍙岀考榻愰鐨勪骇鍝佸紑鍙戠瓥鐣ャ€傚叕鍙哥洰鍓嶅舰鎴愪簡3涓笂甯傞攢鍞骇鍝併€佹暟涓骇鍝佸浜庝复搴婅瘯楠岄樁娈碉紝鍙︽湁澶氫釜浜у搧浣滀负鐮斿彂鍌ㄥ鐨勯樁姊瀷浜у搧寮€鍙戞牸灞€銆侟/span>
姝ゆ鎴愰兘娆ф灄鐢熺墿绉戞妧鏈夐檺鍏徃閲囪喘鎴戝徃鍏ㄨ嚜鍔ㄧ啍鐐逛华涓轰簡鑽搧鐨勭爺鍙戞妸鍏炽€傝€孅/span>Digipol-M70鍏ㄨ嚜鍔?/span>鐔旂偣浠?/span>鏄匠鑸緝楂樼鐨勪竴娆撅紝澶氱敤浜庣鐮旀満鏋勪互鍙婅嵂浼侊紝瀹冪鍚圏/span>21CFR Part 11銆佸璁¤拷韪€佽嵂鍏稿強鐢靛瓙绛惧悕锛屽惈澶氱骇鏉冮檺绠＄悊锛屾暟鎹彲婧簮锛涢搨閲戞俯搴︿紶鎰熷櫒鍝嶅簲閫熷害蹇€佺簿鍑嗗害楂橈紝姣斾紶缁熸柟娉曚娇鐢ㄦ按閾舵俯搴﹁鍏锋湁鏃犲彲姣旀嫙浼樺娍銆侟/span>閫氳繃鏁板瓧鍏夊浼犳劅鍣紝灏嗘暣涓疄楠岃繃绋嬫暟瀛楀寲骞朵紶杈撳埌璁＄畻鏈轰腑锛屾櫤鑳藉寲鐨勮蒋浠跺彲鑷姩鍒ゆ柇鐔旂偣锛屾秷闄や汉涓哄垽鏂啍鐐圭殑涓昏璇樊锛岄檷浣庡疄楠屼汉鍛樼殑鍔冲姩寮哄害銆侟/span>
缁忚繃澶氱暘姣旇緝锛孅/span>鎴愰兘娆ф灄鐢熺墿绉戞妧鏈夐檺鍏徃鍦ㄤ紬澶氬悓绫诲搧鐗屼腑閫夋嫨浣宠埅锛岄潪甯告劅璋㈡澀宸炵晠婧埗鑽湁闄愬叕鍙稿浣宠埅浠櫒鐨勮鍙笌鏀寔銆傛垜浠皢浠ヤ紭璐ㄧ殑浜у搧鍜屽敭鍚庝负鎮ㄦ湇鍔★紝鏈熷緟涓庢垜鍙稿啀娆″悎浣滐紝骞舵杩庣浉鍏虫妧鏈礋璐ｄ汉鍛樹负鎴戝叕鍙告彁鍑哄疂璐电殑鎰忚銆侟/span>
鍏抽敭璇嶏細鎶樺厜浠
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